Teleflex Incorporated has announced FDA 510(k) clearance for restated Indications for Use of the EZ-IO® Vascular Access System. The EZ-IO® 25 mm Needle Set is now indicated for patients 3 kg or over.
Teleflex recently announced its acquisition of Vidacare Corporation, developer of the EZ-IO® Vascular Access System. Vidacare is a leading provider of intraosseous (IO), or inside the bone access devices. By issuing new indications the company hopes to provide physicians with more straightforward selection criteria for these needle sets.
New weight ranges for the EZ-IO® Vascular Access System are now as follows:
EZ-IO® 45 mm Needle 40 kg or over
EZ-IO® 25 mm Needle 3 kg or over
EZ-IO® 15 mm Needle 3 – 39 kg
“In my clinical work in a free-standing, academic pediatric emergency department and level 1 trauma center, as well as in a large community hospital emergency department, rapid identification and treatment of serious conditions is paramount,” states Mark L. Waltzman, MD, FAAP, Chief of Pediatrics, South Shore Hospital, Assistant Professor, Department of Pediatrics at Harvard Medical School and affiliation with the Division of Emergency Medicine at Boston Children’s Hospital. Dr. Waltzman is also a paid consultant for Teleflex. “The restated indication for the EZ-IO® 25 mm Needle Set to be used in patients 3 kg or over will help to avoid confusion and streamline care. Clinicians now will simply assess the tissue depth and choose the correct needle size. This is something we ‘in the trenches’ clinicians have requested from the company and I am gratified they have heard our feedback and pushed for this change.”
“As part of our fight for zero complications in vascular access, we are committed to continuously improving our technologies, enhancing our training and educational initiatives, and partnering with healthcare professionals to provide innovative solutions for treating difficult vascular access patients with the EZ-IO® Vascular Access System,” states Jay White, President and General Manager, Vascular Access Division, Teleflex. “We’re excited about the restated Indications for Use, because we’ve made it even easier for clinicians to select the right needle for their patient.”
Source: Teleflex Incorporated, Business Wire